The Evolution of Medical Device Procurement in Italy
Assobiomedica, the body representing the medical device sector in Italy, published an update to the report ‘Public Policies for the Purchase of Medical Devices’ in October 2018. The report outlines four types of acquisitions for medical devices in Italy:
- Single acquisitions, made by separate healthcare facilities;
- Group acquisitions, made by groups of healthcare facilities, with specific characteristics for every group;
- Centralized regional acquisitions, made by the regional centers for procurement; and
- Purchases made through Consip, a public company in charge of public procurement.
The publication found:
- That between 2007 and 2017, the total amount awarded in public tenders for single or group acquisitions decreased by 60 percent (down from 95% in 2007 to 35% in 2017) and in the same timeframe, increased by the 60 percent for centralized regional acquisitions.
- A negative trend to the number of healthcare facilities participating in one tender, wherein 2009, an average of eight entities engaged in centralized regional acquisitions, while the average for 2017 was three.
- A faster rate for accomplishing acquisitions up from 30 percent over one year in 2007 to 55 percent in six months in 2017.
- High variability for centralized regional acquisitions.
Implications for innovators
Such a robust regional purchasing system may have an undesirable long term effect, negating the immediate decrease in public expenditure.
Some long term impacts on the sector may include:
- The potential exclusion of medium and small companies from the tender process – even if the process is efficiently working and providing innovation – weakening the level of market competition.
- A slowdown to the update of innovative technologies.
Medical device companies seeking to launch innovative products in Italy face a complex reimbursement landscape, with regional and local health authorities having oversight of reimbursement for a new or existing product.
Discussions between companies and Italian decision makers are required to promote value-based procurement mechanisms.
Do you need support with understanding the reimbursement landscape and development of a reimbursement strategy in Italy? Contact us for more information.
On June 25, 2018, the Chinese Ministry of Justice announced amendments to the Supervision and Administration of Medical Devices Regulations (the Regulation) and called for public comment. The proposal is being celebrated by a variety of stakeholders across the medical device and IVD industry following years of lobbying to have the Regulation amended. However, some apprehension regarding the implementation of the proposed Regulation remains. Download the PDF